The Food and Drug Administration recently penalized French pharmaceutical giant Sanofi Pasteur Inc. and drug and beauty chain Watsons Personal Care Philippines for allegedly promoting and advertising the dengue vaccine Dengvaxia illegally.
The FDA said this was a violation of Republic Act No. 9711, or the Food and Drug Act of 2009 and Administrative Order No. 65.
Section 2.3 of AO 65 provides that “No pharmaceutical product classified by BFAD as prescription or ethical drug shall be advertised or promoted in any form of mass media except through medical journal, publications and/or literature solely intended for medical and allied professions.”
Dengvaxia manufactured by Sanofi is classified as a prescription product.
FDA, on a decision dated Oct. 19, slapped both companies with a fine of P5,000.00.
Sanofi and Watsons were given a stern warning by FDA that future violations of FDA-implemented laws, rules and regulations would warrant stiffer sanctions, including the revocation of their license to operate/certificate of product registration, and the closure of their establishments.
